An Electromyography Study Comparing the Impact of Using RMEs on Muscle Activity Among Growing Orthodontic Patients

Malocclusion Clinical Trial

Official title:

An Electromyography Study Comparing the Impact of Using RMEs on Muscle Activity Among Growing Orthodontic Patients (A Prospective Clinical Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02752347
• Other study ID #: FPGRP/43534001/14
• Status: Recruiting
• Phase: N/A
• First received: April 15, 2016
• Last updated: October 6, 2017
• Start date: April 2016
• Est. completion date: December 30, 2017

Study information

• Verified date: October 2017
• Source: Riyadh Colleges of Dentistry and Pharmacy
• Contact: Nancy Ajwa, Residant
• Phone: 0554804564
• Email: nancy.ajwa[@]student.riyadh.edu.sa
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Compare the impact of using rapid maxillary expanders on masticatory muscle activities (Masseter and Anterior Temporalis muscles) among different posterior cross-bite patient (unilateral, bilateral) as well as compare the cross-bite side and non-cross-bite sides of the same preadolescent unilateral crossbite patient before the expansion and after one month of the completion treatment period using surface electromyography device.

Description:

Compare the impact of using rapid maxillary expanders on masticatory muscle activities (Masseter and Anterior Temporalis muscles) between the cross-bite side and non-cross-bite sides of the same preadolescent orthodontic patient before the expansion and after one month of the completion treatment period.

Two channels surface Electromyography sEMG (BioRadio), will be position to record the activity of anterior temporal (AT) and masseter (MM) muscles in three different statuses:

• Rest → patients will instruct to not bite on his/her teeth.

• Clench → patients will instruct to made a maximum voluntary clench on cotton rolls positioned around the first molar, for 5 sec "the cotton clench", and a maximum voluntary clench without the interposed rolls for 5 sec "the "clench".

• This procedure followed the Sforza et al. protocol.

• During function "mastication" → The patients will instruct to chew on a chewing gum for 20 sec (20 continuous masticatory cycles).

Examination frequency:

The patients will be examined two times as follow:

Test 1: Immediately before rapid maxillary expanders cementation, Test 2: 5 months later (1 month after the retention phase).

the same procedure will be done on 35 patients (control group)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 30, 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 15 Years

Eligibility

Inclusion Criteria:

1. Uni-lateral/ or bilateral posterior cross-bite.

2. Patients with erupted permanent maxillary and mandibular first molars.

3. Will be treated by rapid maxillary expanders, (the appliance planning to be worn for approximately 5 months).

4. Age ranged from 9 to 12.

5. Males and females.

6. Not under any medications.

7. Skeletal Class I or Class II (based on ANB angle, convexity, and Wits appraisal).

8. No active caries.

9. Healthy periodontal tissues.

10. Subjects with no signs of TMD or condylar problems.

Exclusion Criteria:

1. History of any functional appliance treatment.

2. Oral, systemic disease or any syndromes.

3. Patients under any medications.

6. Patients with symptoms of Temporomandibular disorders. 4. Neuropathic conditions. 5. Open and deep-bite.

Related Conditions & MeSH terms

• Malocclusion

Intervention

Device:
• Surface EMG device
measuring the muscles activity using surface EMG device

Locations

Country	Name	City	State
Saudi Arabia	Riyadh Colleges of Dentistry and Pharmacy	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
Riyadh Colleges of Dentistry and Pharmacy

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measuring the masticatory muscles activity using electromyography device	the muscle activities of masticatory muscles using surface Electromyography device before and compare it after the maxillary expansion using Rapid Maxillary Expanders (to study the impact of the expanders on the muscles), the muscle activity will be in form of micro volt/second (mV/sec), the data will aggregated then exported on excel sheet in a form of numbers for statistical analysis	Test 1: before cementation of rapid maxillary expander, Test 2: after removal of rapid maxillary expander by 1 month